It was a black Friday indeed for Ocugen, which revealed in the early morning hours after Thanksgiving that the FDA placed a clinical hold on its COVID-19 vaccine.
The agency has ordered a stop to a phase 3 trial of Ocugen's vaccine, known as BBV152 in the U.S. and Covaxin in the countries it has been approved in, according to a Nov. 26 statement. The Pennsylvania biopharma was mum on the details, simply noting the FDA will identify "specific deficiencies" that formed the reasoning for the hold.
Ocugen expects formal written information from the FDA and will work with the agency to "resolve its questions as promptly as possible."
The news comes as the Omicron variant takes root in multiple countries around the world, ringing yet another alarm in the nearly two-year pandemic.
Ocugen has yet to gain a foothold in the U.S. COVID-19 vaccine market, which has been covered by Pfizer and Moderna for nearly 12 months and Johnson & Johnson for about nine months.
But the biopharma's vaccine has been administered more than 100 million times to adults outside the U.S. Branded as Covaxin outside the States, the vaccine is already authorized under emergency use in 17 countries. Applications in 60 additional countries are pending. Covaxin is also on the World Health Organization's list of emergency OK'd vaccines for the pandemic.
The shot will now have to wait to reach the U.S. market after the FDA's move.
The vaccine was 77.8% effective against mild, moderate and severe COVID-19 disease in a phase 3 trial in India in July. At the time, the vaccine also had 65.2% efficacy against the Delta variant, which was quickly spreading.
Covaxin was developed in partnership with Bharat Biotech.